Data / Medical devices / Australia / Aus Systems Pty Ltd.
Aus Systems Pty Ltd.: FDA-registered device maker in ALLENBY GARDENS South Australia, Australia, 1 510(k) clearance
Aus Systems Pty Ltd. is registered with the FDA (registration 3005921952) in ALLENBY GARDENS South Australia, Australia. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 5, 2006. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005921952
- Address
- 3 Charles ST, ALLENBY GARDENS South Australia, Australia, 5009
- Owner or operator
- AUS SYSTEMS PTY LTD. (9076885)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- September 12, 2006
- Registered through
- 2026
- Brand names listed
- RB12 SUCTION RECTAL BIOPSY SYSTEM, SPECIALTY SURGICAL PRODUCTS, INC.
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dilator, Rectal | FFP | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Instrument, Biopsy, Suction | FCK | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 5, 2006 | K062159 | RB12 SUCTION RECTAL BIOPSY SYSTEM | FCK | Substantially Equivalent | Aus Systems Pty , Ltd. | accessdata.fda.gov |
Compare with other makers
Updated September 5, 2006. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.